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Trial registered on ANZCTR


Registration number
ACTRN12615000561583
Ethics application status
Approved
Date submitted
20/04/2015
Date registered
1/06/2015
Date last updated
1/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of short-term exercise on breast cancer survivor
Scientific title
Effects of short-term exercise on breast cancer survivor: Implication towards health and fitness recovery after chemotherapy and postoperative radiotherapy. A pilot study
Secondary ID [1] 286560 0
None
Universal Trial Number (UTN)
U1111-1169-4390
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 294807 0
Condition category
Condition code
Cancer 295083 295083 0 0
Breast
Physical Medicine / Rehabilitation 295209 295209 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eleven female breast cancer survivors (age = 41 – 62 years old) who had completed chemotherapy and postoperative radiotherapy treatment performed Resistance Band Exercise (RBE) for strength training and Aerobic Zumba Dance (AZD) for cardiovascular training for six weeks. Participants took part in RBE (eight exercises for chest, arms, legs, back and abdominal) three times a week for 30 minutes per session and AZD 60 minutes once a week per session. Both RBE and AZD were conducted in a group. RBE is conducted by exercise physiologist including me and AZD is conducted by a dance instructor. Pre and post measurement on VO2 (ml/kg/min), knee and shoulder peak torque (N-m) and BIA including BMI, Skeletal Muscle Mass (SMM), percent body fat (PBF) and waist to hip ratio (WHR) were measured.
Intervention code [1] 291665 0
Treatment: Other
Intervention code [2] 291894 0
Rehabilitation
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294845 0
aerobic outcomes was measured using Hur – Monark 939E cycle ergometer to determine VO2 peak values (ml/kg/min). The Astrand 6 minute sub-maximal test protocol was used.
Timepoint [1] 294845 0
6 weeks
Secondary outcome [1] 314191 0
Strength outcomes was measured using The Biodex Multi-Joint System Pro dynamometer to determine lower and upper body peak torque (N-m) of the quadriceps and hamstrings; shoulders internal and external muscle. The test protocols used were isokinetic unilateral knee extension/flexion at 90/90o.s-1 (low velocity) with contraction CON/CON and unilateral shoulder internal/external rotation at 90/90o.s-1 (low velocity) with contraction CON/CON.
Timepoint [1] 314191 0
6 weeks
Secondary outcome [2] 314588 0
This is a composite secondary outcome which includes Body mass indeks (BMI), skeletal muscle mass (SMM), % body fat (PBF) & waist hip ratio were measured using Body impedance analysis (BIA) machine.
Timepoint [2] 314588 0
6 weeks

Eligibility
Key inclusion criteria
Physically Active Breast cancer survivors who has completed their treatment. There are no restrictions with respect to completion of the therapy.
Minimum age
40 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non breast cancer survivors

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
none
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data was analysed using SPSS version 20. Descriptive statistics (means and standard deviations) were calculated for all variables. Statistical significance levels for all comparisons was set a priori of alpha=0.05. Paired sample-test was used to analyse pre and post mean difference with 95% CI for outcome changes. Health and fitness levels were determined based on VO2 peak values index for Astrand protocol. VO2 peak values index for healthy sedentary individuals are = >37ml/kg/min.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
7/06/2014
Date of last participant enrolment
Anticipated
30/09/2014
Actual
20/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 6828 0
Malaysia
State/province [1] 6828 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 291122 0
University
Name [1] 291122 0
HIR research grant, university Malaya
Country [1] 291122 0
Malaysia
Primary sponsor type
University
Name
Malaysian breast cancer cohort (MyBcc), University Malaya
Address
HIR University Malaya, Lembah Pantai, 50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 289797 0
Hospital
Name [1] 289797 0
University Malaya medical centre (UMMC)
Address [1] 289797 0
University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
Country [1] 289797 0
Malaysia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56638 0
Mr Gabriel Lingesh
Address 56638 0
University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
Country 56638 0
Malaysia
Phone 56638 0
+60174349709
Fax 56638 0
Email 56638 0
[email protected]
Contact person for public queries
Name 56639 0
Gabriel Lingesh
Address 56639 0
University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
Country 56639 0
Malaysia
Phone 56639 0
+60174349709
Fax 56639 0
Email 56639 0
[email protected]
Contact person for scientific queries
Name 56640 0
Gabriel lingesh
Address 56640 0
University Malaya Medical Centre, Lembah Pantai 50603, Kuala Lumpur, Malaysia
Country 56640 0
Malaysia
Phone 56640 0
+60174349709
Fax 56640 0
Email 56640 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.